Guidance on Information Requirements and Chemical Safety Assessment

PATHFINDER

This guidance describes the information requirements under REACH with regard to substance properties, exposure, use and risk management measures, in the context of the chemical safety assessment. It is part of a series of guidance documents that are aim to help all stakeholders with their preparation for fulfilling their obligations under the REACH Regulation.

The Guidance covers:

the collection of available information regarding the intrinsic properties of substances to be registered

the assessment of this information against the requirements specified by REACH,

the identification of data gaps and

the generation of the additional information required to fill the data gaps.

The Guidance also aims to assist industry in conducting Chemical Safety Assessments and preparing Chemical Safety Reports, when required. A CSR may be required as part of a registration dossier (for non intermediates > 10 t/a), as part of an authorisation application, or as part of downstream user obligations. It also sets out the basic principles for authorities preparing a risk assessment. This may be needed in support of a restriction proposal, of a proposal to include substances into the authorisation regime, or as part of a Substance Evaluation.

The Guidance consists of two major parts: Concise guidance (Part A to F) and supporting reference guidance (Chapters R.2 to R.20).

Figure 1: Structure of the Guidance

The purpose of the concise guidance is to support the processes needed to meet the information requirements on intrinsic properties of substances to be registered, and where relevant to carry out a chemicals safety assessment. This includes information collection processes, communication processes and assessment processes. The purpose of the reference guidance is to provide in-depth scientific and technical advice. The links between the concise guidance and the supporting reference guidance are illustrated in Figure 1.

Figure 2 above presents an overview of the overall process of collecting and assessing existing information on the intrinsic properties of a substance, including identification of needs to generate new data. It also describes the process of chemical safety assessment additionally required for substances produced/imported in amounts of more than 10t per year.

Figure 3 below illustrates to which steps in the overall process a particular guidance element is related.

Figure 3: Relationship between the process steps and the guidance elements

Structure of the Guidance on Information Requirements and Chemical Safety Assessment

Part A

Part A provides an introduction to the guidance for conducting the chemical safety assessment and preparing the chemical safety report for substances manufactured or imported in a quantity of 10 tonnes or more per year (Chapter A.1). This includes an overview on the intended outcomes and main contents of the chemicals safety assessment (CSA). It also includes the overall approach to making cost-effective decisions during the iterative process of conducting the CSA, and a pathfinder to the different elements of this guidance. Chapter A.2 explains the key facts needed to understand the process of making a chemical safety assessment. The communication and tasks within the supply chain related to the chemical safety assessment are outlined in Chapter A.3. Chapter A.4 describes in more detail, under what conditions an actor may need to carry out a CSA under REACH.

Part B contains concise guidance on hazard assessment. This covers information requirements on intrinsic properties of a substance under REACH, including information gathering, non-testing approaches and the so-called 'integrated testing strategies' for generating the relevant and required information on each endpoint. Part B also provides concise guidance on how to characterise hazards, including where possible derivation of DNELs and PNECs. Each of the sections in Part B corresponds to the more in-depth guidance contained in Chapters R.2 to R.10. This includes:

Physico-chemical properties in Section R.7.1

Determination of Derived No-Effect-Levels (DNEL) (or other qualitative or semi-quantitative measures of potency of the substance) in Chapter R.8 and the corresponding chapters of integrated testing strategies for the relevant human health endpoints (Sections R 7.2 to R.7.7 in Chapter 7a). These Sections in Chapter R.7 also include information on how to derive appropriate information for classification and labelling of the substance. However, the guidance on classification and labelling itself is provided elsewhere. See current Annex VI to Directive 67/548 and future Guidance on Classification, Packaging and Labelling related to the future GHS system .

Determination of Predicted No-effect-Effect levels (PNEC) in Chapter R.10 and the corresponding chapters of integrated testing strategies for the environment endpoints (Sections R.7.8 to R.7.11 in Chapter R.7b and R.7c).These sections in Chapter R.7 also include information on how to derive appropriate information for classification and labelling of the substance. However, the rules on classification and labelling themselves are provided elsewhere. See current Annex VI to Directive 67/548 and future Guidance on Classification, Packaging and Labelling related to the future GHS system. Section 7.13 in Chapter 7c provides guidance related to the particular assessment approaches for hydrocarbons and metals.

Overall framework for meeting the information requirements on intrinsic properties of substances (Chapter R.2), guidance on collection of available information (Chapter R.3), evaluation of information (Chapter R.4), guidance on exposure-driven waiving and exposure-triggered testing as well as other adaptations of information requirements (Chapter R.5), in depth guidance on non-testing approaches (Chapter R.6).

Part C contains the concise guidance on how to assess whether or not a substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). In-depth guidance on the PBT and vPvB assessment, including emission characterisation is covered in Chapter R.11.

Part D details how to develop exposure scenarios and related exposure estimation. This part contains detailed workflows on how to identify uses in the supply chain, how to develop exposure scenarios and finalise them based on the iterations necessary for controlling risks. Chapter D.2 describes the core contents of an exposure scenario under REACH. It presents an overview of the most common determinants of exposure and recommends a standard format for the final exposure scenario. This also includes a list of the most common types of operational conditions (OC) and risk management measures (RMM) to be considered in ES development. Chapter D.3 suggests a standard workflow of 14 steps, including the main outputs to be delivered. Chapter D.4 provides guidance on developing the contents of an exposure scenario: Activities in the life cycle, description of use and title of exposure scenario, (preset) initial exposure scenarios, conditions of use for controlling risks. Chapter D.5 provides an overview on exposure estimation. This includes guidance on the role of measured data as well as a brief explanation of a number of tools available to estimate exposure. Chapter D.6 briefly describes situation where, based on initial exposure assessment, the M/I may conclude that refinement of the hazard assessment is needed, before the final exposure scenario can be derived. Chapter D.7 briefly explains the risk characterisation since the risk characterisation potentially triggers iterations of the initial exposure scenario. More details on risk characterisation are provided in Part E of the guidance. Chapter D.8 contains guidance on how to finalise the exposure scenario. This includes how to integrate the operational conditions and risk management measures for the relevant exposure routes and target groups into a consistent final exposure scenario for a specific use or uses. Finally, Chapter D.9 builds the bridge to the use of exposure scenarios in the context of the CSR and the extended safety data sheet (eSDS), and makes reference to Part F and Part G of the guidance.

Part D provides also links to more in-depth guidance on exposure assessment, in particular how to describe uses, how to collect information on operational conditions and risk management measures, and how to carry out exposure estimates. This includes:

Brief general description of identified uses and how to give exposure scenarios a short title (Chapter R.12)

Risk management measures and operational conditions for building of exposure scenarios, including guidance on how to determine the effectiveness of risk management measures and how to make use of the risk management library initially set up during the development of the current guidance (Chapter R.13).

Please note, that a new format, simplified and better aligned with industry tools such as ESCom, has been developed in the context of ECHA's Chemical Safety Assessment and Reporting Tool (Chesar) development. The revised ES format as well as instructions for using it can be found in Chesar Manual 6, Annex 1 at the following link:http://chesar.echa.europa.eu/documents/2326902/2424433/chesar2_user_manual_part6_en.pdf It is up to the individual registrant to decide which exposure scenario (ES) format he wants to use, as long as the content of the ES is compliant with the requirements set out in Annex I to REACH.

Part E contains the guidance on the risk characterisation. In risk characterisation, information on hazard and exposure is combined in the risk characterisation ratio or in qualitative risk characterisation. Both types of information contain uncertainty which needs to be assessed in order to decide on the robustness of the risk estimate. The uncertainty analysis is further detailed in Chapter R.19. Part E also includes guidance on qualitative risk characterisation with regard to non-threshold substances.

Part F details the format and requirements for preparing the chemical safety report, which documents the results of the entire chemical safety assessment. Part F details subsections to the main headings as laid down in section 7 of Annex 1 of REACH and provides guidance on how to present the outcome of the CSA. This includes guidance on how to use the CSR template as published on the ECHAs website.

Please note, the tables embedded in Section 9.1.1 of the Appendix to Guidance F are obsolete. See also the CSR template under Formats for Industry.

Please also note, ECHA's Chemical safety assessment and reporting tool Chesar supports the generation of the CSR. If you wish to report your chemical safety assessment in a format similar to the Chesar format, you can download a DOT document

Part G

Please, note that Part G of the IR&CSA guidance has been made obsolete and hence removed from the ECHA website. The information has been updated and transferred to two more appropriate Guidance documents which have been recently revised. In particular:

- information on extending the safety data sheet and on how exposure scenario information is communicated and implemented by actors within the supply chain has been updated and included into Appendix 2 to the revised Guidance on the compilation of safety data sheets (version 2.0);

- information on the use of scaling by the downstream user when evaluating whether he operates within the boundaries of the exposure scenario communicated to him has been updated and integrated into the revised Guidance for downstream users (version 2.0).

New practical examples on scaling are currently being developed to take into account the new experience gathered. These will be published when finalised. The old examples have therefore not been transferred to the revised guidance documents.

Please note that Chapter R.9 is now obsolete. The content of the obsoleted Chapter R.9 has been revised and merged into an updated sub-chapter R.7.1 "Physicochemical properties" within "Chapter R.7a: Endpoint specific guidance of the Guidance on information requirements and chemical safety assessment".